Kornimate/medical-research-clean huggingface dataset:
trial of novel oral zinc cysteine preparation in alzheimer's disease

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: this trial aims to test the hypothesis that 1) a single dose of zinc cysteine in a proprietary gastro-retentive form will produce sustained blood levels of zinc giving a larger bioavailable amount of zinc than an fda approved preparation of inorganic zinc acetate; and 2) that the zinc cysteine gastro-retentive, sustained-release preparation will be better tolerated with significantly less gastrointestinal side effects than the zinc acetate capsules. the trial also tests the hypothesis that, after 6 months of once daily administration, the zinc cysteine subjects will show reduced serum non-ceruloplasmin copper. additionally, subjects will perform tests of mental function,including the dementia rating scale, the mini mental status examination and the adas-cognitive performance test aimed at alzheimer's status assessment. tests will be administered at baseline, 3 and 6 months, and the performance results compared. care-giver assessments will also be noted.

this multi-center study aims to determine the pharmacokinetics and pharmacodynamics of a novel gastro-retentive, sustained-release zinc cysteine preparation on the blood and urine measures of copper and zinc balance in alzheimer's disease and mild cognitive impairment. data expected to be derived include tolerability of the novel preparation in comparison with oral inorganic zinc salt, and long-term effects on primarily blood-measured copper-zinc balance. the study design is that of a prospective, randomized, double blind placebo-controlled clinical trial, with a duration for individual subjects of 6 months. the study will be performed at a total of 3 sites, under the direction of a single principal investigator, with a sub-investigator. the statistical plan calls for a comparison of data from the two long-term parallel groups using anova and other applicable techniques. in addition to blood parameters, mental function assessments obtained at baseline, 3 and 6 months will be evaluated statistically.

Eligibility criteria:
inclusion criteria: * alzheimer's disease mild to moderate as diagnosed by standard clinical, functional and ninda-adrda criteria * mild cognitive impairment diagnosed by standard clinical, functional and ninda-adrda criteria * all subjects able to swallow tablets * subjects taking copper or zinc containing supplements must have a 30-day wash out before starting study materials * screening laboratory values either within normal limits or deemed not clinically significant by investigator exclusion criteria: * subjects or their study companions/care givers unable to give adequate informed consent * presence of a disease or condition known to affect biometal homeostasis * presence of psychosis, substance abuse or other major medical or neurological issues * presence of vascular dementia * clinically significant anemia at the time of the screening visit * current use of a decoppering drug such as trientine or penicillamine

Keywords: alzheimer's disease mild cognitive impairment copper metabolism zinc metabolism ceruloplasmin
adolescent mental health: canadian psychiatric risk and outcome study

Conditions: Psychotic Disorders; Depressive Disorder, Major; Bipolar Disorder

Summary: the primary study aims are to determine the clinical, behavioural and social predictors of smi development in youth, and to investigate whether neuroimaging can distinguish youth who will develop smi from those who will not. the study's secondary aims are to examine the proportions of the cohort that make transitions between the different clinical stages of risk, and to determine the proportions that have poor outcomes, defined as ongoing or increased symptoms, secondary substance misuse, poor social or role functioning, i.e., non-participation in education, or employment, and new self-harm. investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group; n=160), youth at risk due to a family history of a smi (family high risk (fhr); n=40), and healthy controls (hc; n=40). from this cohort, clinical, social and cognitive data, as well as imaging data will be gathered to create a multi-layered "snapshot" of these individuals and provide full-level characterization. investigators will use the full range of clinical and imaging data generated from this cohort to develop novel prediction algorithms incorporating key variables that predict the development of smi.


Eligibility criteria:
inclusion criteria: * participants will understand and sign an informed consent (or assent for minors) document in english. exclusion criteria: * meet criteria for current or lifetime axis i bipolar or psychotic disorder (other axis i disorders will not be exclusionary as they may be precursors to mood or psychotic disorders); * iq \< 70; * past or current history of a significant central nervous system disorder or serious medical disorder; and * current pharmacological treatment that would be considered as an adequate trial of treatment for a smi.

Keywords: attenuated psychotic symptoms
contrast bath and sympathetic skin response

Conditions: Stroke; Sympathetic Disorder

Summary: this study evaluates the effects of contrast bath on sympathetic skin response in stroke patients with complex regional pain syndrome .

contrast bath(cb) is a thermal modality. it is usually performed by keeping hands in hot and cold water for certain periods of time. cb is a mostly advised intervention in complex regional pain syndrome (crps) altough there is no certain evidence the investigators will study on stroke patients. change in sympathetic skin response after the contrast bath will be evaluated. stroke patients who admitted to the inpatient rehabilitation programme in istanbul physical medicine and rehabilitation training and research hospital were evaluated for this study. patients who had crps after stroke were included in the study (crps group). also patients who had not crps and had similar age, gender and stroke duration with crps group were included in control group. stroke patients with pacemaker, polyneuropathy, neglect, sensory or motor aphasia, peripheral nerve injury, hand surgery and reynauld disease were excluded from the study. age, gender, dominant arm, comorbidities, stroke side, aetiology and duration were recorded. brunnstrom stages were used to evaluate arm and hand. spasticity of upper extremity was assed by modified aschworth scale. in crps group, crps severity scale was performed to evaluate the crps severity. this scale includes sensorial, autonomic and motor function. also, neuropathic pain was assesed by douleur neuropathique 4 (dn4) questionnaire and visual analog scale(vas). contrast bath was performed to patients' plegic side . there were two baths , one include hot water and other had cold degrees. patients hold their plegic hands in hot water for 4 minutes, in cold water for 1 minute after hot water. hot and cold bath were repeated four times. sympathetic skin response (ssr) was measured before the contrast bath and 30 minutes after the contrast bath finished. ssr was recorded from plegic side and contralateral side. the active electrode was placed at the palm of the hand and the reference electrode at dorsum of the hand to record the median nerve ssr. the latency and the amplitude of ssr was measured.

Eligibility criteria:
inclusion criteria: * stroke * both gender exclusion criteria: * peripheral neuropathy * pace maker * skin lesion in hands * anxiety * sensory or motor aphasia * peripheral nerve injury * hand surgery and * reynauld disease
the effect of mild weight loss on circulating metabolite profiles

Conditions: Visceral Fat; Weight Loss

Summary: to determine whether low calorie diet (lcd)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a lcd (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (uplc-ltq/orbitrap ms).

Eligibility criteria:
inclusion criteria: * able to give informed consent * 20-65 years old * males and females * overweight (25.0 kg/m²≤ body mass index \<30 kg/m²) * nondiabetic (fasting glucose \<126 mg/dl) exclusion criteria: * unstable body weight (body weight change \>1 kg within 3 months before screening) * consumption of medication that affects body weight or energy expenditure * pregnancy or breast-feeding * hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease * liver disease, kidney disease, or gastrointestinal disease * acute or chronic infections * any acute or chronic disease requiring treatment

Keywords: high visceral fat low calorie diet mild weight loss metabolomics metabolites acylcarnitines
to evaluate safety and efficacy of ec-18 in covid-19 infection to pneumonia

Conditions: COVID-19

Summary: prevention of covid-19 infection to severe pneumonea or ards


Eligibility criteria:
inclusion criteria: * signed informed consent * male or female age 19 years or older * pathologically confirmed diagnosis of covid-19 infection to pneumonia exclusion criteria: * pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia * pregnant or nursing at the time of signing informed consent * known sensitivity to any study medication * unwilling or unable to complete study diary * any other condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the protocol
a facebook-based weight loss programme for obese adults in hong kong

Conditions: Obesity

Summary: the purpose of this study is to determine the feasibility and efficacy of a 6-month weight loss intervention program for obese working adults through a popular social networking site - facebook.

obese individuals often are at higher risk for developing non-communicable diseases such as diabetes and cardiovascular disease. the regular physical activity, healthy diet and social support have been shown to be beneficial for weight loss. this is a two-arm parallel design randomized controlled trial for 6 months. participants who completed the baseline assessment will be randomly allocated, after stratified by gender, to either a control group or facebook-based intervention group. the control group will receive information on healthy eating, physical activity, obesity and cancer via three government printed health pamphlets. in addition to the government health pamphlets, the intervention group will receive a programme delivered through facebook. the interventions include participation in a private research group on facebook for health education, self monitoring and social support. participants will receive 12 weekly lessons related to nutrition, physical activity, chinese food therapy, acupressure, weight loss. a registered nutritionist and a registered chinese medicine practitioner will join the facebook group as health partners. both of them are also registered nurses. data collection will be carried out at baseline, 3 months and 6 months. each time, both groups will complete online questionnaires and attend in-person anthropometric measurements

Eligibility criteria:
inclusion criteria: * university full-time employees; * age 18 to 60 years, * bmi of 25 to 40 kg/m2, * have access to internet and facebook; * able to communicate in both english and chinese at f.5 secondary school level or above. * agree to communicate with internet, email, facebook group and respect privacy. exclusion criteria: * smoker; * an unstable medical or mental status; * history of myocardial infarction or stroke, or cancer in the past 5 years; * orthopedic or joint problems that would prohibit exercise; * in treatment for alcohol or drug dependency; * an eating disorder; * pregnant, breastfeeding, or planning on becoming pregnant within the next 6 months; * use of medication that might affect body weight; * a recent weight loss of more than 4.5 kg in the previous 6 months; * currently participating in a weight loss program; * organic obesity; * unable to attend assessments or increase physical activity.

Keywords: chinese population acupressure physical activity nutrition facebook
looking for asymptomatic mpox in a population at high risk

Conditions: Mpox (Monkeypox)

Summary: mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. while the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. to do this, a canadian sample of gay, bisexual and other men who have sex with men (gbmsm) who are participating in a randomized controlled trial will be screened for mpox symptoms. screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. approximately 450 individuals will be recruited. the results will be descriptive in nature.


Eligibility criteria:
inclusion criteria: - participants need to have been enrolled in an existing randomized clinical trial (nct04762134) exclusion criteria: - none
orthopilot elite post-market clinical follow-up

Conditions: Degenerative Osteoarthritis; Rheumatoid Arthritis; Posttraumatic Arthropathy; Instability, Joint; Stiffness of Knee, Not Elsewhere Classified; Deformity of Knee

Summary: prospective, multicenter, observational, comparative clinical trial on the equivalence of two different orthopilot® navigation system generations applied for computer-assisted total knee arthroplasty

the study is designed as a prospective, non-interventional, multicenter, comparative cohort study. the product under investigation will be used in routine clinical practice and according to the authorized instructions for use (ifu). those data that are obtained in routine clinical use will be documented in the case report form (crf). the study design is based on a two-arms design. the patients for the both groups will be recruited consecutively, starting with group a. the study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation \>3° from neutral alignment is defined as an outlier.

Eligibility criteria:
inclusion: inclusion criteria: * patients with indication for total knee arthroplasty using the aesculap orthopilot® navigation system and a corresponding primary implant * dated and signed informed consent exclusion: exclusion criteria * pregnancy * patients \< 18 years * patients unable to participate at the follow-up examination (physically, mentally) * previous joint replacement at the indexed knee

Keywords: navigation computer assisted orthopedic surgery orthopilot® total knee arthroplasty
e-cigarette - dna adducts

Conditions: Smoking; Cigarette Smoking; Electronic Cigarettes

Summary: this study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. additionally, the study will look at the effect of varying voltage levels for e-cigarette users.

in this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the minneapolis-st. paul area. this research will be conducted at the tobacco research programs at the university of minnesota. subjects are screened for eligibility over the phone. if eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. subjects who eligible will be asked to return for six visits over the course of six months. at these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). saliva will be collected before and after a smoking or vaping session. non-users will only have 1 saliva collection. subjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.

Eligibility criteria:
inclusion criteria: * good physical health with no unstable medical conditions; able to provide written informed consent; stable and good mental health; meet criteria for 1 of three groups: 1. regular smokers confirmed by co; 2. e-cigarette users (exclusive e-cigarette use for 3 months); non-tobacco users 3. non-smokers exclusion criteria: * unstable medical condition not willing to attend visits

Keywords: tobacco e-cigarettes toxicants formaldehyde dna adducts oxidative damage
the efficacy of an artificial intelligence platform to adapt visual aids for patients with low vision: a randomised controlled trial

Conditions: Ophthalmology; Low Vision Aids; Artificial Intelligence

Summary: according to the who's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. although china is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting. traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. at present, there are almost no intelligent fitting models of assisting devices in the world. therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in fujian province, china in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.


Eligibility criteria:
inclusion criteria: * low vision aged 3 to 105 exclusion criteria: * severe systemic diseases failure to sign informed consent or unwilling to participate
optical genome mapping in hematological malignancies

Conditions: MDS; ALL; Other Hematologic Malignant Neoplasms

Summary: establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer


Eligibility criteria:
inclusion criteria: * minor/major patients * patients with suspected hemopathies for whom we receive a sample for diagnosis in the chromosomal genetics laboratory or for whom a diagnosis of hemopathy has already been made. * no objection made or consent given exclusion criteria: * patients under judicial protection (guardianship, curatorship, ...), * refusal to participate
coenzyme q10 as a symptomatic treatment in parkinson's disease

Conditions: Parkinson's Disease

Summary: this study was designed to evaluate the symptomatic effects of coenzyme q10 nanodispersed solution in middle-stage parkinson's disease (pd) patients (hoehn\&yahr ii to iii). the treatment phase includes three months period of 300 mg coenzyme q10 per day or placebo. the primary outcome measure was the combined unified parkinson's disease rating scale (updrs) part ii and iii. the hypothesis of this study was that coenzyme q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in pd patients.

this study was designed to evaluate the symptomatic effects of coenzyme q10 nanodispersed solution in middle-stage non-fluctuating parkinson's disease (pd) patients (hoehn\&yahr ii to iii). the treatment phase includes three months period of 300 mg coenzyme q10 per day or placebo. the design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. the intervention includes 100 mg coenzyme q10 nanodispersion (nanoquinon solution) tid or matched placebo for three months. participating study centers include neurological university outpatient clinics and neurological departments of community-based hospitals experienced with pd patients. the primary outcome measure was the combined unified parkinson's disease rating scale (updrs) part ii and iii. the hypothesis of this study was that coenzyme q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in pd patients. main inclusion criteria: * parkinson's disease according to the uk brain bank criteria * hoehn \& yahr stadium ii until iii * age 40 to 75 years * updrs part iii \> 15 points * no motor fluctuations or dyskinesias * stable medication for 4 weeks prior to inclusion main exclusion criteria: * atypical parkinsonian syndromes * dyskinesias or motor fluctuations * coenzyme q10 treatment in the past * pregnancy

Eligibility criteria:
inclusion criteria: * parkinson's disease according to the uk brain bank criteria * hoehn \& yahr stadium ii until iii * male or female * age 40 to 75 years * updrs part iii \> 15 points * no motor fluctuations or dyskinesias * stable parkinsonian condition for 4 weeks prior to inclusion * outpatients * patients without or with stable levodopa treatment for 4 weeks prior inclusion * written informed consent exclusion criteria: * atypical or drug-induced parkinsonian syndromes * dyskinesias or motor fluctuations * coenzyme q10 treatment in the past * pregnancy * epileptic seizures in the history * hypothyroidism * severe medical conditions with interference with study drug * treatment with cse inhibitors, thyroidal hormones, antiarrhythmic drugs, warfarin, metformin * treatment or intake of vitamins, magnesium, vitamin e, calcium

Keywords: parkinson's disease coenzyme q10 treatment neuroprotection